CN1382474A - Chinese medicine for treating periodontal disease and its preparing process and application - Google Patents

Chinese medicine for treating periodontal disease and its preparing process and application Download PDF

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CN1382474A
CN1382474A CN02111656A CN02111656A CN1382474A CN 1382474 A CN1382474 A CN 1382474A CN 02111656 A CN02111656 A CN 02111656A CN 02111656 A CN02111656 A CN 02111656A CN 1382474 A CN1382474 A CN 1382474A
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periodontal disease
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朱建中
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Priority to EP02762210A priority patent/EP1504763A4/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/70Polygonaceae (Buckwheat family), e.g. spineflower or dock
    • A61K36/704Polygonum, e.g. knotweed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/19Acanthaceae (Acanthus family)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/39Convolvulaceae (Morning-glory family), e.g. bindweed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/40Cornaceae (Dogwood family)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/484Glycyrrhiza (licorice)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/80Scrophulariaceae (Figwort family)
    • A61K36/804Rehmannia
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/86Violaceae (Violet family)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/97Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
    • A61K8/9783Angiosperms [Magnoliophyta]
    • A61K8/9789Magnoliopsida [dicotyledons]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/02Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61QSPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q11/00Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses

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Abstract

An oral-applied Chinese medicine for treating periodontal disease is prepared from 8 Chinese-medicinal materials including prepared fleece flower root, rhemannia root, liquorice root, turtle shell, etc. through supercritical CO2 fluid extraction to part of said raw materials. It features sure curative effect.

Description

A kind of Chinese medicine preparation, preparation method and application for the treatment of periodontal disease
Technical field
The present invention relates to Chinese medicine preparation and preparation method, be specifically related to a kind of Chinese medicine preparation, preparation method and application for the treatment of periodontal disease.
Background technology
Periodontal disease is human common frdquently encountered disease, and whole world All Countries all can't be avoided.China more than 35 years old adult's sickness rate up to 98%.So far, worldwide still there is not ideal special effect medicine.
China's Chinese medicine is thought " kidney governing bones is tooth after the bone ".Deficient when the human body kidney yin, then bone loses and to moisten fosterly, and tooth is dredged for it and slitted admittedly, makes loose compact, masticatory atonia; The then gastric heat of suffering from a deficiency of the kidney, hyperactivity of deficient fire, red swelling of gingiva pain; Insufficiency of the spleen, then make us the whole body function reduction, the unable poison heresy of resisting is attacked, and in this, then periodontal disease is frequently shown effect.
Modern medicine is thought, the periodontal disease cause of disease mainly contains two aspects, (1) oral cavity flora is actuated down in inside and outside composite factor, produce the long disorder that disappears, lose the balance of relative group of ratio, a large amount of rapidly breedings of aerobe and the anaerobe of mainly causing a disease, bacterial plaque bulk deposition, produce a large amount of toxic metabolites and bacterial endotoxin, periodontal tissue is caused infection; (2) human body self immunologic hypofunction, imbalance makes patient self can't suppress the damage of main pathogenic bacterium to periodontal tissue, the various symptoms of allergic immune reaction and periodontal disease inflammation occur.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of compatibility scientific and reasonable, treating both the principal and secondary aspects of a disease in conjunction with Chinese medicine and modern medical theory, periodontal disease therapeutic medicine evident in efficacy.
The Chinese medicine preparation of treatment periodontal disease disclosed by the invention be with Radix Polygoni Multiflori Preparata, the Radix Rehmanniae, Radix Glycyrrhizae, to give birth to Carapax Trionycis, dogwood meat processed, Semen Cuscutae, Herba Andrographis and Herba Violae be the medically acceptable oral formulations that active ingredient and pharmaceutic adjuvant are made, wherein active ingredient percentage by weight proportioning is Radix Polygoni Multiflori Preparata 18-25%, Radix Rehmanniae 11-18%, Radix Glycyrrhizae 3-7%, give birth to Carapax Trionycis 11-17%, dogwood meat processed 7-15%, Semen Cuscutae 4-11%, Herba Andrographis 4-12%, Herba Violae 8-15%.
Oral formulations of the present invention is meant: hard capsule, soft capsule, tablet, pill, granule, oral liquid etc.
Another technical problem to be solved by this invention is to adopt modern extraction technique to disclose the preparation method of the Chinese medicine preparation of above-mentioned treatment periodontal disease.
The preparation method of the oral formulations of treatment periodontal disease disclosed by the invention comprises the following steps:
One, Herba Andrographis active ingredient extract preparation
Press recipe quantity with the Folium Andrographis drying, pulverize, cross 20 mesh, put extraction kettle, airtight; Pressure 18-32Mpa; 28 ℃-45 ℃ of temperature; CO 2Flow 800ml/h-1250ml/h; Use 70%-99% ethanol, circulating load 80ml/h-125ml/h; After the 2-4h extraction; Extract is taken out in decompression, and other puts; Medicinal residues are dried and crushed into 220 orders-280 order utmost point powder, and other puts, and is stand-by;
Two, the Radix Rehmanniae, living Carapax Trionycis, Radix Polygoni Multiflori Preparata, Semen Cuscutae, the preparation of dogwood meat processed active ingredient extract
Respectively by prescription measure the Radix Rehmanniae, give birth to Carapax Trionycis, Radix Polygoni Multiflori Preparata, Semen Cuscutae, system taro meat all and, pulverized 40 orders, put the one-level extraction kettle, pressure Mpa8-18; 52 ℃-70 ℃ of temperature; 65%-85% ethanol circulating load 100ml/h-150ml/h; CO 2Flow 1000ml/h-1500ml/h; After the 2h-4h extraction; Decompression 8Mpa/-15Mpa, 45 ℃-55 ℃ of temperature flow into detached dowel, enter extraction-container again, be decompressed to positive normal pressure after, take out extract, other puts; Medicinal residues are collected stand-by;
Three, preparation active ingredient preparation
Press recipe quantity with Radix Glycyrrhizae, Herba Violae is pulverized 20 orders, adds the medicinal residues of step 2, puts in the reaction pot that condenser is housed, and adds 6 times of water gagings respectively, 4 times of water gagings, and 2.5 times of water gagings decoct three times; Collect condenser ethereal oil aqueous mixtures, waste and fry in shallow oil juice even three times filters, and adds oil water mixture in the filtrate, mixes; Be evaporated to proportion 1-1.25 thick paste, add step 1 extract and step 2 extract, mix homogeneously, cold drying is ground into 220 orders-280 order impalpable powder; Add the Herba Andrographis impalpable powder that step 1 makes in the impalpable powder, stir promptly;
Four, the preparation of capsule, tablet, granule, pill
Get active ingredient medicated powder and pharmaceutic adjuvant compatibility that above-mentioned steps three makes, make capsule, tablet, granule, pill etc. with conventional method;
Five, oral liquid preparation
By recipe quantity Herba Andrographis is pulverized 20 orders, get 10 times of airtight immersion 24h of amount ethanol (70%-99%, 10 ℃-25 ℃) and separate pure immersion, circumfluence method reclaims ethanol, and surplus liquid is put in addition; Medicinal residues are put in addition, and are stand-by;
Press recipe quantity with Radix Glycyrrhizae, the Herba Violae and the Radix Rehmanniae, give birth to Carapax Trionycis, Radix Polygoni Multiflori Preparata, Semen Cuscutae, 20 orders are pulverized in the oven dry of system taro meat, add the Herba Andrographis medicinal residues, the reaction pot that input has condensing unit adds 8 times of water gagings respectively, 6 times of water gagings, 2 times of water gagings, be fried boiling for three times, each 1.5h collects the ethereal oil aqueous mixtures of condenser, and waste mixes fries in shallow oil juice three times, filters, the Herba Andrographis alcohol extract is added in the filtrate, filtrate decompression concentrates, to 60 ℃ of concentration be proportion 1.06-1.10, be cooled to 10-25 ℃, adding ethereal oil aqueous mixtures adds correctives again and antiseptic is an amount of, promptly.
Technical problem to be solved by this invention is to disclose the application of above-mentioned Chinese medicine preparation in preparation treatment periodontal disease medicine.
Preparation of the present invention can be used for the red swelling of gingiva that caused by periodontal disease, and hemorrhage, suppuration, floating, the pain of tooth pine can't be chewed and have a fever the treatment of diseases such as headache.
Therapeutic dose is every day 3 times, and each 3, every contains former medicine 6.0-8.0mg, and 2-7 days is a course of treatment.
" tooth person, the institute of bone eventually, the institute of marrow is supported, the excess of the kidney master it, so renal failure then tooth slit essence Sheng, then tooth heavily fortified point." the Chengdu stomatological hospital. bend strong ", (" the Sichuan traditional Chinese medical science " 11 volume second phases are P.46).At present, the treatment periodontal disease is many with heat clearing away class medicine.Heat clearing away class medicine " not only have to press down and kill antibacterial, virus, leptospira, protozoon, effects such as fungus also have neutralization virus ..., improve reactivity of organism "; It mainly contains the following aspects effect: " 1, resisting pathogenic microbes; 2, antibacterium toxin; 3, analgesic 4, antiinflammatory 5, to Immune Function; Antipyretic also can strengthen hypophysis---adrenal cortex function ".(" Chinese Chinese medicine developed 50 years " published Meng Qingyun .P119-120 in 1999).
Preparation of the present invention in same preparation, is paid attention to heat clearing away, antiinflammatory, removing heat from blood, antidotal simultaneously at the deficiency of traditional heat-clearing formula in the treatment periodontal disease, has taken into account nourishing the liver and kidney, strengthens the spleen and stomach.When improve to press down killing pathogenic bacterium, improved the immunity of human body to pathogenic infection, suppress allergy.To human body integral deficiency and excess overall balance, short-term control improves the periodontal disease symptom.That is: kidney governing bones is a tooth after the bone, and kidney yin is deficient, then bone lose moisten foster, tooth dredge for it slit loosening, masticatory atonia; Deficiency of the kidney void is gastric heat then, hyperactivity of deficient fire, then red swelling of gingiva, pain; Insufficiency of the spleen, it is evil long then just to disappear, and the whole body function reduces, and periodontal disease is frequently shown effect.The Radix Polygoni Multiflori, the Radix Rehmanniae are specially gone into Liver and kidney, and be tonic Kidney-Yin, rescues strong the resembling of Gu Yangyuan; Semen Cuscutae be spleen, liver, kidney three through the tonification key medicine, empty person can mend, real person can be sharp, cold person can temperature, wet person can be dry, dry person can be moistened, the strong liver of spleen is normal, kidney qi is when solid, kidney yin is when keeping, this three flavor is monarch drug.Give birth to Carapax Trionycis, system taro meat is dived and is held back kidney-Yang, pain relieving, and heat extraction, it is tired to disappear, and strengthening bone and muscle is to think minister.Herba Violae, Herba Andrographis, the removing heat from blood detumescence, heat-clearing and toxic substances removing, this two flavor is assistant.Radix Glycyrrhizae, invigorating the spleen and replenishing QI, relieving spasm to stop pain, heat clearing away, detoxifcation, coordinating the actions of various ingredients in a prescription, this is the envoy.All medicines are pulled together, nourishing kidney-yin then, and nourishing the liver blood, spleen invigorating soil is let out the deficiency and excess pathogenic fire clearly, sharp liver, removing heat from blood, treating both the principal and secondary aspects of a disease brings out the best in each other, and makes all diseases of periodontal disease, is readily solved.
The preparation method of traditional compound Chinese medicinal preparation adopts water extraction and alcohol extracting method, the time long (about 6 days), temperature height (100 ℃) makes in the effective ingredient easily oxidizedly at leaching process to heat-labile material, decomposes, polymerization, and isomerization, and extract impurity is more.The big effective ingredient of many molecular weight is arranged, and because of the boiling point height, volatility is little, adopts water extraction and alcohol extracting method to obtain, and has both caused energy consumption big, makes loss of effective components again, and total yield is on the low side, the herb resource waste, and influencing preparation should be effective in cure.
In the preparation method of the present invention, the part medical material has been taked the supercritical carbon dioxide extraction technology, extraction temperature low (about 25 ℃-45 ℃), the time short (2-5 hour), the saving energy, organic solvent-free is residual, steady quality.Because supercritical carbon dioxide fluid has strong dissolving power to the part liposoluble constituent, high osmosis and high mass transfer rate, loss of effective components in the no extraction process, and be in the dissolubility unsaturated state in the extraction process all the time, avoid bad phenomenon such as effective ingredient decomposes, oxidation, polymerization, isomerization to take place, the primary characteristic that can farthest keep each component, extract fragrance nature.Simultaneously under the high pressure effect, big to many molecules, the boiling point height, the active substance that volatility is little, supercritical carbon dioxide fluid can more effectively and intactly extract, and makes yield mean height 3.5-4 times in traditional extraction method, as vegetable polysaccharides and plant lactone etc., guarantee the due usefulness of preparation, improved the curative effect of medicine.
The present invention also is used in combination efflux of solids extractum superfine grinding (fineness is greater than 250 orders), has improved people's absorbability, has improved bioavailability of medicament.
" detoxicating tablet of cow-bezoar " is treatment periodontal disease kind targetedly, and area coverage is very big in clinical practice, is the good agent of heat clearing and inflammation relieving of generally acknowledging.
The present invention is a matched group with " detoxicating tablet of cow-bezoar ", and preparation of the present invention is carried out relevant clinical verification:
Test group: preparation of the present invention, specification 700mg/ sheet, dosage form: thin film special-shaped tablets.
Matched group: detoxicating tablet of cow-bezoar, 600mg/ sheet
Dosage: 700mg *2/time, 3 times/day
Administration time: 7 days; Get rid of and take other any medicines; In full accord.
Clinical symptoms: 1, red swelling of gingiva; 2, gingiva pain; 3, gingival hemorrhage; 4, odontoseisis; 5, sting lip pain.
Periodontal disease index: gingival index (G1); Sulcular bleeding index (SB1); Depth of pocket (PD); Tooth mobility (MD).
Result of the test:
1, administration is forward and backward, and experimental group G1, SB1, PD, MD all have highly significant (improvement) difference (P<0.01); Matched group G1, SB1 have significantly (improvement) difference (P<0.01), and the equal no significant difference of PD, MD (P>0.05).
2, clinical symptoms compares before and after the administration
Test group Matched group
Symptom Be clearly better Take a turn for the better The commentaries on classics of not getting better Be clearly better Take a turn for the better The commentaries on classics of not getting better
????1 ??83.3% ??16.7% ????0 ??13.3% ??23.3% ??63.4%
????2 ??100% ??0 ????0 ??46.8% ??26.6% ??26.6%
????3 ??63.4% ??33.3% ????3.3% ??13.3% ??36.7% ??50%
????4 ??92.3% ??7.7% ????0 ??4.0% ??8.0% ??88%
????5 ??92.0% ??8.0% ????0 ??37.5% ??41.7% ??20.8%
Effective percentage ??????????????86.20% ????????????????22.98%
Result of the test shows that preparation of the present invention can effectively be controlled periodontal disease in 2-7 days, and curative effect is significantly better than detoxicating tablet of cow-bezoar.
The Chinese medicine preparation that the present invention treats periodontal disease has been taken into account nourishing the liver and kidney at heat clearing away, antiinflammatory, removing heat from blood, antidotal simultaneously, strengthen the spleen and stomach, improve press down kill pathogenic bacterium in, improved the immunity of human body to pathogenic infection, treating both the principal and secondary aspects of a disease, evident in efficacy.The newtype drug of a kind of determined curative effect, taking convenience is provided for the treatment of periodontal disease.
The specific embodiment: embodiment 1, the preparation of preparation active component
(1) Folium Andrographis drying is pulverized, and crosses 20 orders, puts extraction kettle, and is airtight; Pressure 19.8Mpa; 35 ℃ of temperature; CO 2Flow 820ml/h; Use 78% ethanol, circulating load 82ml/h; Behind 4h; Extract is taken out in decompression.Other puts; Medicinal residues are dried and crushed into 220 order impalpable powders, and other puts, and is stand-by.
(2) Radix Rehmanniae, give birth to Carapax Trionycis, Radix Polygoni Multiflori Preparata, Semen Cuscutae, system taro meat all and, pulverized 40 orders, put the one-level extraction kettle, pressure 10Mpa; 55 ℃ of temperature; 78% ethanol circulating load 108ml/h; CO 2Flow 1180ml/h; Behind 3h; Decompression 10.8Mpa, 48 ℃ of temperature flow into detached dowel, enter extraction-container again, be decompressed to positive normal pressure after, take out extract, other puts; Medicinal residues are collected stand-by;
(3) Radix Glycyrrhizae, Herba Violae are pulverized 20 orders, add the medicinal residues in the step (2), and put the reaction pot that condenser is housed and add 6 times of water gagings respectively, 4 times of water gagings, 2.5 times of water gagings decoct respectively three times; Collect condenser ethereal oil aqueous mixtures, waste and fry in shallow oil juice even three times filters, and adds oil water mixture in the filtrate, mixes.Be evaporated to proportion 1.25 thick pastes, add the Herba Andrographis extract in the step (1), the Radix Rehmanniae, living Carapax Trionycis, Radix Polygoni Multiflori Preparata, Semen Cuscutae, system taro meat mixed extracts in the step (2), cold drying is ground into 220 order impalpable powders; Add step (1) Herba Andrographis impalpable powder in the impalpable powder, stir.
Embodiment 2, coated tablet preparation
Prescription: total crude drug amount is 6300g
Radix Polygoni Multiflori Preparata 20%, the Radix Rehmanniae 15%, Radix Glycyrrhizae 5%, living Carapax Trionycis 15%, dogwood meat processed 15%, Semen Cuscutae 11%, Herba Andrographis 8%, Herba Violae 11%
Right amount of auxiliary materials is made the 700mg/ sheet, 1000
Get above-mentioned prescription, make the preparation active component by embodiment 1 method, tabletting, hot Icing Sugar is a clothing, makes the heavy 700mg tablet of sheet.
Embodiment 3, capsule preparation
Prescription: total crude drug amount is 6300g
Radix Polygoni Multiflori Preparata 22%, the Radix Rehmanniae 15%, Radix Glycyrrhizae 5%, living Carapax Trionycis 13%, dogwood meat processed 13%, Semen Cuscutae 13%, Herba Andrographis 10%, Herba Violae 9%
Right amount of auxiliary materials is made the 350mg/ grain, totally 2000
Get above-mentioned prescription, make the preparation active component, be filled in the glue shell promptly by embodiment 1 method.
Embodiment 4, dragee preparation
Prescription: total crude drug amount is 7000g, makes 8000 altogether
Radix Polygoni Multiflori Preparata 20%, the Radix Rehmanniae 14%, Radix Glycyrrhizae 8%, living Carapax Trionycis 14%, dogwood meat processed 14%, Semen Cuscutae 10%, Herba Andrographis 10%, Herba Violae 10%
Right amount of auxiliary materials
(1) Folium Andrographis drying is pulverized, and crosses 20 orders, puts extraction kettle, and is airtight; Pressure 19.8Mpa; 35 ℃ of temperature; CO 2Flow 820ml/h; Use 78% ethanol, circulating load 82ml/h; Behind 4h, extract is taken out in decompression.Other puts, and medicinal residues are dried and crushed into 220 order impalpable powders, and other puts, and is stand-by.
(2) Radix Rehmanniae, give birth to Carapax Trionycis, Radix Polygoni Multiflori Preparata, Semen Cuscutae, system taro meat all and, pulverized 40 orders, put the one-level extraction kettle, pressure 10Mpa; 55 ℃ of temperature; 78% ethanol circulating load 108ml/h; CO2 flow 1180ml/h; Behind 3h; Decompression 10.8Mpa, 48 ℃ of temperature flow into detached dowel, enter extraction-container again, be decompressed to normal after, take out extract, other puts; Medicinal residues are collected stand-by;
(3) Radix Glycyrrhizae, Herba Violae are pulverized 20 orders, add (2) Chinese medicine slag, and put the reaction pot that condenser is housed and add 6 times of water gagings respectively, 4 times of water gagings, 2.5 times of water gagings decoct respectively three times; Collect condenser ethereal oil aqueous mixtures, waste and even the collection are fried in shallow oil juice three times, filter, and add oil water mixture in the filtrate, mix.Be evaporated to 1.25 thick pastes, add Herba Andrographis extract in (1), the Radix Rehmanniae, living Carapax Trionycis, Radix Polygoni Multiflori Preparata, Semen Cuscutae, system taro meat mixed extracts in (2), cold drying is ground into 220 order impalpable powders; And and go into Herba Andrographis impalpable powder in (1), machine-processed ball, the pill of per 8 heavy 700mg.
Embodiment 5, oral liquid preparation
Total crude drug amount of filling a prescription is 2850Kg, makes 1000 bottles
Radix Polygoni Multiflori Preparata 24%, the Radix Rehmanniae 18%, Radix Glycyrrhizae 5%, living Carapax Trionycis 12%, dogwood meat processed 12%, Semen Cuscutae 10%, Herba Andrographis 5%, Herba Violae 14%
Right amount of auxiliary materials is made the 500ml/ bottle.
By recipe quantity Herba Andrographis is pulverized 20 orders, get the airtight immersion 24h of 10 times of amount ethanol (78%, 25 ℃) immersion and separate pure immersion, circumfluence method reclaims ethanol, and surplus liquid is put in addition; Medicinal residues are put in addition, and are stand-by;
Get Radix Glycyrrhizae, Herba Violae and the Radix Rehmanniae, living Carapax Trionycis, Radix Polygoni Multiflori Preparata, Semen Cuscutae, system taro meat oven dry pulverizing 20 orders by recipe quantity, add the Herba Andrographis medicinal residues, the reaction pot that input has condensing unit adds 8 times of water gagings respectively, 6 times of water gagings, 2 times of water gagings, be fried boiling for three times, each 1.5h collects the ethereal oil aqueous mixtures of condenser, and waste mixes fries in shallow oil juice three times, filters, the Herba Andrographis alcohol extract is added in the filtrate, filtrate decompression concentrates, to 60 ℃ of concentration be 1.06, be cooled to 25 ℃, adding ethereal oil aqueous mixtures adds correctives again and antiseptic is an amount of, and bottling promptly.Embodiment 6, dry syrup (granule) agent preparation
Prescription: total crude drug amount 72Kg, make 1000 bags
Radix Polygoni Multiflori Preparata 24%, the Radix Rehmanniae 12%, Radix Glycyrrhizae 5%, living Carapax Trionycis 14%, dogwood meat processed 14%, Semen Cuscutae 11%, Herba Andrographis 8%, Herba Violae 12% right amount of auxiliary materials are made the 15g/ bag, granule.
(1) Folium Andrographis drying is pulverized, and crosses 20 orders, puts the 50L extraction kettle, and is airtight; Pressure 19.8Mpa; 35 ℃ of temperature; CO 2Flow 820ml/h; Use 78% ethanol, circulating load 82ml/h; Behind 4h; Extract is taken out in decompression.Other puts; Medicinal residues are dried and crushed into 220 orders-280 order utmost point powder, and other puts, and is stand-by.
(2) Radix Rehmanniae, give birth to Carapax Trionycis, Radix Polygoni Multiflori Preparata, Semen Cuscutae, system taro meat all and, pulverized 40 orders, put the one-level extraction kettle, pressure flows into detached dowel, enters extraction-container again, pressure 10Mpa; 55 ℃ of temperature; 78% ethanol circulating load 108ml/h; CO 2Flow 1180ml/h; Behind 3h; Decompression 10.8Mpa, 48 ℃ of temperature, be decompressed to positive normal pressure after, take out extract, other puts; Medicinal residues are collected stand-by;
(3) Radix Glycyrrhizae, Herba Violae are pulverized 20 orders, add (2) Chinese medicine slag, and put the reaction pot that condenser is housed and add 6 times of water gagings respectively, 4 times of water gagings, 2.5 times of water gagings decoct respectively three times; Collect condenser ethereal oil aqueous mixtures, waste is collected and is fried in shallow oil juice three times, filters, and adds oil water mixture in the filtrate, mixes.Be evaporated to 1.25 thick pastes, add extract in (1) and (2), cold drying is ground into 220 order impalpable powders; Add the Herba Andrographis impalpable powder in the impalpable powder, stir; The system granule, oven dry, dress 15g/ bag, promptly.
Embodiment 7, soft capsule preparation
Prescription: total crude drug 31.5Kg, make 2000
Radix Polygoni Multiflori Preparata 20%, the Radix Rehmanniae 14%, Radix Glycyrrhizae 5%, living Carapax Trionycis 14%, dogwood meat processed 14%, Semen Cuscutae 9%, Herba Andrographis 10%, Herba Violae 14%
Right amount of auxiliary materials is made the 2500mg/ grain, soft capsule.
(1) Folium Andrographis drying is pulverized, and crosses 20 orders, puts extraction kettle, and is airtight; Pressure 19.8Mpa; 35 ℃ of temperature; CO 2Flow 820ml/h; Use 78% ethanol, circulating load 82ml/h; Behind 4h; Extract is taken out in decompression.Other puts; Medicinal residues are dried and crushed into 220 order impalpable powders, and other puts, and is stand-by.
(2) Radix Rehmanniae, give birth to Carapax Trionycis, Radix Polygoni Multiflori Preparata, Semen Cuscutae, system taro meat all and, pulverized 40 orders, put the one-level extraction kettle, pressure pressure 10Mpa; 55 ℃ of temperature; 78% ethanol circulating load 108ml/h; CO 2Flow 1180ml/h; Behind 3h; Decompression 10.8Mpa, 48 ℃ of temperature flow into detached dowel, enter extraction-container again, be decompressed to positive normal pressure after, take out extract, other puts; Medicinal residues are collected stand-by;
(3) Radix Glycyrrhizae, Herba Violae are pulverized 20 orders, add (2) Chinese medicine slag, and put the reaction pot that condenser is housed and add 6 times of water gagings respectively, 4 times of water gagings, 2.5 times of water gagings decoct respectively three times; Collect condenser ethereal oil aqueous mixtures, waste is collected and is fried in shallow oil juice three times, filters, and adds oil water mixture in the filtrate, mixes.Be evaporated to 1.25 thick pastes, add (1) and (2) extract, cold drying is ground into 220 order impalpable powders; Add the ethereal oil aqueous mixtures, add purification medicinal oil and stir well; Add the suspendible stabilizing agent, be mixed with suspendible shape medicinal liquid;
(4) gelatin routinely, glycerol, anion water, medicinal pigment stirs, and makes the mixed glue solution of dissolubility unanimity;
(5) glue and suspendible shape medicinal liquid are mixed with in proportion factice liquid wrap up soft ball, the heavy 700mg of every ball inclusions, the soft ball of shape is put 40 ℃ of oven dry, with the anhydrous solvent washing, promptly.

Claims (5)

1, a kind of Chinese medicine preparation for the treatment of periodontal disease, it is characterized in that said preparation be with Radix Polygoni Multiflori Preparata, the Radix Rehmanniae, Radix Glycyrrhizae, to give birth to Carapax Trionycis, dogwood meat processed, Semen Cuscutae, Herba Andrographis and Herba Violae be the medically acceptable oral formulations that active ingredient and pharmaceutic adjuvant are made.
2, a kind of Chinese medicine preparation of treatment periodontal disease as claimed in claim 1, the percentage by weight proportioning that it is characterized in that active ingredient in the said preparation is Radix Polygoni Multiflori Preparata 1 8-25%, Radix Rehmanniae 11-18%, Radix Glycyrrhizae 3-7%, give birth to Carapax Trionycis 11-17%, dogwood meat processed 7 one 15%, Semen Cuscutae 4-11%, Herba Andrographis 4-12%, Herba Violae 8-15%.
3, a kind of Chinese medicine preparation of treatment periodontal disease as claimed in claim 1 is characterized in that wherein said oral formulations is meant hard capsule, soft capsule, tablet, pill, granule and oral liquid etc.
4, a kind of preparation method of Chinese medicine preparation of treatment periodontal disease as claimed in claim 1 is characterized in that this method comprises the following steps:
One, Herba Andrographis active ingredient extract preparation
Press recipe quantity with the Folium Andrographis drying, pulverize, cross 20 mesh, put extraction kettle, airtight; Pressure 18-32Mpa; 28 ℃-45 ℃ of temperature; CO 2Flow 800ml/h-1250ml/h; Use 70%-99% ethanol, circulating load 80ml/h-125ml/h; After the 2-4h extraction; Extract is taken out in decompression, and other puts; Medicinal residues are dried and crushed into 220 orders-280 order utmost point powder, and other puts, and is stand-by;
Two, the Radix Rehmanniae, living Carapax Trionycis, Radix Polygoni Multiflori Preparata, Semen Cuscutae, the preparation of dogwood meat processed active ingredient extract
Respectively by prescription measure the Radix Rehmanniae, give birth to Carapax Trionycis, Radix Polygoni Multiflori Preparata, Semen Cuscutae, system taro meat all and, pulverized 40 orders, put the one-level extraction kettle, pressure Mpa8-18; 52 ℃-70 ℃ of temperature; 65%-85% ethanol circulating load 100ml/h-150ml/h; CO 2Flow 1000ml/h-1500ml/h; After the 2h-4h extraction; Decompression 8Mpa/-15Mpa, 45 ℃-55 ℃ of temperature flow into detached dowel, enter extraction-container again, be decompressed to positive normal pressure after, take out extract, other puts; Medicinal residues are collected stand-by;
Three, preparation active ingredient preparation
Press recipe quantity with Radix Glycyrrhizae, Herba Violae is pulverized 20 orders, adds the medicinal residues of step 2, puts in the reaction pot that condenser is housed, and adds 6 times of water gagings respectively, 4 times of water gagings, and 2.5 times of water gagings decoct three times; Collect condenser ethereal oil aqueous mixtures, waste and fry in shallow oil juice even three times filters, and adds oil water mixture in the filtrate, mixes; Be evaporated to the 1-1.25 thick paste, add step 1 extract and step 2 extract, mix homogeneously, cold drying is ground into 220 orders-280 order impalpable powder; Add the Herba Andrographis impalpable powder that step 1 makes in the impalpable powder, stir promptly;
Four, the preparation of capsule, tablet, granule, pill
Get active ingredient medicated powder and pharmaceutic adjuvant compatibility that above-mentioned steps three makes, make capsule, tablet, granule, pill etc. with conventional method;
Five, oral liquid preparation
By recipe quantity Herba Andrographis is pulverized 20 orders, get the airtight immersion 24h of 10 times of amount ethanol (70%-99%, 10 ℃-25 ℃) immersion and separate pure immersion, circumfluence method reclaims ethanol, and surplus liquid is put in addition; Medicinal residues are put in addition, and are stand-by;
Press recipe quantity 20 orders are pulverized in Radix Glycyrrhizae, Herba Violae and the Radix Rehmanniae, living Carapax Trionycis, Radix Polygoni Multiflori Preparata, Semen Cuscutae, the oven dry of system taro meat, add the Herba Andrographis medicinal residues, the reaction pot that input has condensing unit adds 8 times of water gagings respectively, 6 times of water gagings, 2 times of water gagings, be fried boiling for three times, each 1.5h collects the ethereal oil aqueous mixtures of condenser, and waste mixes fries in shallow oil juice three times, filters, the Herba Andrographis alcohol extract is added in the filtrate, filtrate decompression concentrates, to 60 ℃ of concentration be 1.06-1.10, be cooled to 10-25 ℃, adding ethereal oil aqueous mixtures adds correctives again and antiseptic is an amount of, promptly.
5, the application of a kind of Chinese medicine preparation as claimed in claim 1 in preparation treatment periodontal disease medicine.
CNB021116563A 2002-05-14 2002-05-14 Chinese medicine for treating periodontal disease and its preparing process and application Expired - Fee Related CN1241598C (en)

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CNB021116563A CN1241598C (en) 2002-05-14 2002-05-14 Chinese medicine for treating periodontal disease and its preparing process and application
AU2002328571A AU2002328571A1 (en) 2002-05-14 2002-08-19 Traditional chinese pharmaceutical formulation for treatment of paradentosis, process for preparation and use thereof
US10/514,209 US7179492B2 (en) 2002-05-14 2002-08-19 Traditional chinese pharmaceutical formulation for treatment of paradentosis, process for preparation and use thereof
EP02762210A EP1504763A4 (en) 2002-05-14 2002-08-19 Traditional chinese pharmaceutical formulation for treatment of paradentosis, process for preparation and use thereof
PCT/CN2002/000576 WO2003094941A1 (en) 2002-05-14 2002-08-19 Traditional chinese pharmaceutical formulation for treatment of paradentosis, process for preparation and use thereof

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CN103099902B (en) * 2011-11-09 2015-02-18 上海中医药大学附属龙华医院 Traditional Chinese medicine composition for treating subacute thyroiditis and preparation method thereof
CN103735634B (en) * 2014-01-08 2016-01-06 广州发元生物科技有限公司 There is Chinese medicine composition of blackening and nourishing hair effect and preparation method thereof

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CN1241598C (en) 2006-02-15
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